Clinical trial data
Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 men. In three 12-month, placebo-controlled, double-blind, multicentre studies of comparable design, the overall safety profiles of finasteride and placebo were similar.
Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with finasteride and 2.1% of 934 men treated with placebo.
Table 1 presents the only clinical adverse effects considered possibly, probably or definitely medicine- related by the investigator, for which the incidence on finasteride was =1% and greater than placebo over the 12 months of the study.
|Medicine-Related Adverse Effects|
In addition, in the 12-month controlled studies, decreased volume of ejaculate was reported in 0.8% of men treated with finasteride and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with finasteride and in many who continued therapy. In a separate study, the effect of finasteride on ejaculate volume was measured and was not any different from that seen with placebo.
The incidence of each of the above side effects decreased to < 0.3% by the fifth year of treatment with finasteride.
Who can’t use Finasteride
Use in pregnancy
Category X: Medicines which have such a high risk of causing permanent damage to the foetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
A&M - Fintab 1 is contraindicated for use in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to DHT in some tissues, these medicines, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Women who are or may potentially be pregnant should not handle crushed or broken tablets of A&M - Fintab 1 mg, or handle tablets with wet hands, because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. Whole tablets are coated to prevent contact with the active ingredient during normal handling.
Use in lactation
A&M - Fintab 1 is not indicated for use in women and should not be used by lactating women. It is not known whether finasteride is excreted in human milk
Use in the elderly
Clinical studies with A&M - Fintab 1 have not been conducted in elderly men with male pattern hair loss.